Description

Lcz-696 Impurity 60 is a high-purity chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient Sacubitril/Valsartan (LCZ696). This impurity is critical for ensuring the safety and efficacy of the final drug product by enabling accurate identification and quantification during manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality assurance departments, and contract research organizations (CROs) involved in the development and production of cardiovascular medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and routine quality control testing of Sacubitril/Valsartan (LCZ696) API and finished dosage forms.
• Analytical Research: Used in HPLC, UPLC, and LC-MS studies for the identification, characterization, and quantification of process-related impurities and degradation products.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity profiles and specifications.
• Stability Studies: Employed as a marker compound in forced degradation and long-term stability studies to monitor impurity formation over time.
• Process Chemistry Optimization: Used by chemical development scientists to monitor and minimize the formation of this specific impurity during API synthesis and purification steps.

Basic Information

Product Name	Lcz-696 Impurity 60
CAS No.	1174131-27-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	LCZ696 Impurity 60; Sacubitril/Valsartan Impurity 60; Valsartan Sacubitril Impurity 60; (2R,4S)-5-Biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid 2-(tetrazol-5-yl)-biphenyl-4-ylmethyl ester; Entresto Impurity 60; AHU-377/Valsartan Impurity 60
EINECS	Contact for details

Quality Control

Every batch of Lcz-696 Impurity 60 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic and spectroscopic techniques (HPLC, LC-MS, NMR) to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA), detailing batch-specific results, is provided with each shipment to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.